Autologel Process Centrifuge, Model B4360 (100-103, 100-129)
FDA 510(k) K030340 · Cytomedix
510(k) numberK030340
Submission
- Device name
- Autologel Process Centrifuge, Model B4360 (100-103, 100-129)
- Applicant
- Cytomedix
Walker, MN, US - Received
- January 31, 2003
- Decision date
- April 11, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JQC – Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2050
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JQC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K183205 | PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic…JQC · Special | Emcyte Corporation | 05/30/2019SESU |
| K103340 | SMARTPREP2 Bmac System, Smartprep Platelet Concentration SystemJQC · Special | Harvest Technologies, Corp. | 12/06/2010SE |
| K081345 | Axp Platform Marrow Xpress System Model 8-5137, 8-5138, 8-5139, 8-5140 (Primary)JQC · Abbreviated | Thermogenesis Corp. | 07/10/2008SN |
| K071934 | Marrowstim Concentration Kit and Marrowstim Mini Concentration KitJQC · Traditional | Biomet Manufacturing Corp | 10/11/2007SE |
| K070666 | Genesiscs Component Concentrating SystemJQC · Traditional | Perfusion Partners & Assoc., Inc. | 06/20/2007SE |
| K052925 | SMARTPREP2 Centrifuge SystemJQC · Traditional | Harvest Technologies, Corp. | 01/04/2006SE |
| K042473 | Cobe Angel Whole Blood Separation SystemJQC · Abbreviated | Cobe Cardiovascular, Inc. | 11/19/2004SE |
| K024080 | Secquire Cell SeparatorJQC · Traditional | Perfusion Partners & Assoc., Inc. | 07/02/2003SE |
| K030555 | GPS Platelet Separation Kit with Anticoagulant Acd-AJQC · Traditional | Biomet, Inc. | 04/11/2003SE |
| K021902 | Magellan Autologus Platelet Separator, MAG100, Magellan Autologous Platelet Separator…JQC · Traditional | Medtronic Vascular | 08/12/2002SE |
Questions and answers
When was Autologel Process Centrifuge, Model B4360 (100-103, 100-129) cleared by the FDA?
Autologel Process Centrifuge, Model B4360 (100-103, 100-129) (K030340) received a 510(k) decision of Substantially Equivalent on April 11, 2003, 70 days after the submission was received.
What is the product code of K030340?
The FDA product code is JQC – Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2050.